510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K891948 | Tru-Touch Vinyl Exam Gloves (Belgium) | BD Becton Dickinson Vacutainer Systems Preanalytic | LYZ | Class I | |
| K891940 | Patient Exam Gloves (Mfg. Moss Point Glove Co.) | Tillotson Corp. | LYY | Class I | |
| K891939 | Non Sterile Exam Gloves ( Tillotson Rubber Co.) | Tillotson Corp. | LYY | Class I | |
| K891937 | Patient Examination Gloves (Latex) | Kosel Industries Sdn Bhd | LYY | Class I | |
| K891933 | Patient Examination Gloves (Latex) | Prowell Industries Sdn. Bhd. | LYY | Class I | |
| K891916 | Ite Prescription Series Model Pp + F | Us Hearing Centers, Inc. | ESD | Class I | |
| K891915 | Ite Prescription Series Model Lp | Us Hearing Centers, Inc. | ESD | Class I | |
| K891876 | Patient Examination Gloves (Latex) | United Cargo System, Inc. | LYY | Class I | |
| K891857 | Patient Examination Gloves (Latex) | General Merchandise Co. | LYY | Class I | |
| K891852 | Megatex Patient Examination Gloves (Latex) | Mega Wijaya Sdn. Bhd. | LYY | Class I | |
| K891840 | Vinyl Examination Gloves | Maxcare, Inc. | LYZ | Class I | |
| K891802 | Patient Examination Gloves (Latex) | Addwealth Industrial, Ltd. | LYY | Class I | |
| K891791 | Accu-Touch Latex Exam Gloves, Unisize & Large | MEDLINE INDUSTRIES, LP - Northfield | LYY | Class I | |
| K891781 | Toxo Elisa Test System | Zeus Scientific LLC | LGD | Class II | |
| K891749 | Patient Examination Gloves (Latex) | Ocean Pacific Med Tec | LYY | Class I | |
| K891722 | Latex Exam Gloves (Mfg. Shanghai Meheco) | Amerimed US Corp. | LYY | Class I | |
| K891720 | Pulltex Brand (Patient Exam Gloves - Latex) | Pulley Rubber Corp. | LYY | Class I | |
| K891655 | Patient Examination Gloves (Latex) | Penflex Corp. Sdn. Bhd. | LYY | Class I | |
| K891642 | Patient Examination Gloves (Latex) | Interpro Intl., Inc. | LYY | Class I | |
| K891641 | Patient Examination Gloves (Latex) | Global Latex Products Sdn Bhd | LYY | Class I | |
| K891625 | Nonsterile Latex Examination Gloves | World Spring Industries Corp. | LYY | Class I | |
| K891503 | Patient Examination Gloves | New Moda Sdn Bhd | LYY | Class I | |
| K891502 | Patient Examination Gloves (Latex) | Rindumas Sdn Bhd | LYY | Class I | |
| K891500 | Excelcare Patient Examination Gloves | Modern Health Care Products | LYY | Class I | |
| K891379 | Patient Examination Gloves (Vinyl) | Lcl Taiwan & Co., Ltd. | LYZ | Class I | |
| K891373 | Tracor Ra500 Audiometer | Tracor Instruments Austin, Inc. | EWO | Class II | |
| K891284 | Patient Examination Gloves | Real Latex Pvt., Ltd. | LYY | Class I | |
| K891281 | Interpleural Anesthesia Kit W/polyurethane Cath. | Arrow Intl., Inc. | CAZ | Class II | |
| K891174 | Patient Examination Gloves (Latex) | Howard Associates, Inc. | LYY | Class I | |
| K891134 | Patient Examination Glove (Latex) | Grupo Industrial Supertex S.A. de C.V. | LYY | Class I | |
| K891123 | Rubbercare Patient Examination Glove | Perusahaan Pelindung Getah (M) Sdn Bhd | LYY | Class I | |
| K891110 | Latex Patient Examination Gloves | I Horng Industrial Co., Ltd. | LYY | Class I | |
| K891102 | Shield Brand (Patient Examination Glove) | Poly Shield Industries (Malaysia) Sdn. Bhd. | LYY | Class I | |
| K891010 | Nr Latex Examination Gloves | Universal Bodycare (I) Sdn. Bhd. | LYY | Class I | |
| K890974 | Patient Examination Glove | Barriermed, Inc. | LYY | Class I | |
| K890891 | Latex Examination Gloves (Mfg. Ningbo Medical) | Interpro Intl., Inc. | LYY | Class I | |
| K890858 | Patient Examination Gloves | Rejuvena Ent. Co., Ltd. | LYY | Class I | |
| K890746 | Myotest Dbs Nerve Stimulator | Biometer Intl. A/S | BXN | Class II | |
| K890713 | Overdenture - Stud Attachment | Austenal Dental, Inc. | DZE | Class II | |
| K890676 | Disposable Transducer Manifold | L.O.N. Research, Inc. | DTL | Class II | |
| K890124 | Ilo88 Otodynamic Analyzer Screening Audiometer | Grason-Stadler, Inc. | EWO | Class II | |
| K890096 | Bladder Cycler Closed-System Urinary Drain Bag | Medical Inventors Corp., Inc. | FCN | Class II | |
| K885175 | Myopore(tm) Unipolar Sutureless Myocardial Leads | Possis Medical, Inc. | DTB | Class III | |
| K885058 | Cardiocap(tm) Dr-104 Reporter | Datex Division Instrumentarium Corp. | DSF | Class I | |
| K884505 | Basal/bolus Infusors | Baxter Healthcare Corporation | FRN | Class II | |
| K884495 | Surgical Gloves | Sanko Chemical Industry Co., Ltd. | KGO | Class I | |
| K883896 | Neurotrain | Sterne Equipment Co., Ltd. | LIH | Class II | |
| K883871 | Epstein-Barr Viral Capsid Antigen Igm #5590 | Clinical Sciences, Inc. | LSE | Class I | |
| K883870 | Epstein-Barr Viral Capsid Antigen Igg #4590 | Clinical Sciences, Inc. | LSE | Class I | |
| K892955 | Patient Examination Gloves (Latex) | Awb Ent., Inc. | LYY | Class I |